The FDA regulates the majority of packaged foods sold in the United States, mandating specific elements that must be included on the packaging, such as a Nutrition Facts panel and an ingredient statement. To sell your food products, compliance with the FDA’s Food Product Labeling and Packaging laws is essential unless your operation qualifies for an exemption. Explore with GOL Solutions to learn more about how the FDA regulates the majority of packaged foods.

Packaging Areas

Before discussing placement, it’s important to understand the names and locations of each area on the package.

Principal Display Area

This is the area most likely to be seen by a buyer at the time of purchase. For a rectangular container like a cereal box, the PDP (Principal Display Panel) area is calculated by multiplying the height by the width. For a cylindrical container like a can, the PDP area is 40 percent of the product of the height and the circumference.

Information Panel

The information panel is the panel (or space, if the package is cylindrical) immediately to the right of the PDP (Principal Display Panel).

Required Packaging Elements and Placement

Statement of Identity

The Statement of Identity is the legal name of the food (e.g., Nilla Wafers), the common name of the food (e.g., peanut butter), or, when the other two are not appropriate, a description of the food (e.g., whole green peas). This is distinct from the brand name (e.g., Kellogg’s).

Placement: The Statement of Identity must be placed on the PDP (Principal Display Panel) as one of the primary art elements. The font type height should be, at a minimum, half the size of the largest font on the package.

Net Quantity of Contents

Net quantity indicates the amount of food in the package, shown as weight, fluid measure, or number of items.

Placement: This should be placed in the bottom 30 percent of the PDP in a type height determined by the total PDP area, according to the specified chart.

Nutrition Facts Label

The Nutrition Facts Label communicates important information about the food. The FDA governs the label format based on package size and contents.

The Nutrition Facts Label must show:

• Serving size (Consult the RACC to determine this)
• Household measure/common household unit
• Servings per container
• Mandatory nutrients (total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, potassium)

Placement: Generally, place the Nutrition Facts Label on the PDP or the Information Panel, near the ingredient statement.

Ingredient Statement

You must display the ingredient statement on the same panel as the manufacturer’s information. Ingredients are listed in descending order of weight, in a type at least 1/16” tall and easy to read.

Placement: Generally, place the Ingredient Statement on the PDP or the Information Panel, near the Nutrition Facts Label.

Allergen Declaration

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandates that packaged food items declare, in plain language, the presence of any major food allergens (Milk, Egg, Fish, Crustacean shellfish, Tree nuts, Wheat, Peanuts, Soybeans, Sesame) on the product packaging.

Placement: Generally, place the Allergen Declaration on the PDP or the Information Panel, near the Nutrition Facts Label.

Allergens may appear either

• In a parenthetical directly after the name of the ingredient within the ingredient statement. Example: Peanut butter (peanuts), casein (milk), spice (sesame)…
• OR in a separate “Contains” statement. Example: Contains peanuts, milk, and sesame.

Name and Address of the Manufacturer, Packer, or Distributor

The food package must show the name of the manufacturer (or packer/distributor, accompanied by a qualifying phrase that states the firm’s relationship to the product, e.g., “manufactured for” or “distributed by”) and the full street address.

Placement: Most often, this goes on the Information Panel, but it can also appear on the PDP.

Additional Information

Nutrient Content Claims

A Nutrient Content Claim is any statement regarding a nutrient level in your food (e.g., “low fat,” “high fiber,” “sugar-free”).

Regulations: Regulations determine what claims are valid.

Placement: Claims can be displayed on the PDP, Information Panel, or anywhere else on the package, in a type size that can’t be larger than twice the size of the font used for the Statement of Identity.

Important: If you choose to use a Nutrient Content Claim on your package, you must have a Nutrition Facts Panel showing that nutrient and its value.

Barcode

No government regulatory agency requires that your food package have a barcode. However, most retail establishments will. The barcode must be placed in a manner where it doesn’t interfere with the required elements.

Best Before, Expiration, or Sell-By Date

Some states require dates on some foods. You will need to check into the specific regulations for your state and food.

Placement: The date cannot interfere with required labeling elements and must show the month, day, and year immediately adjacent to an explanatory phrase (e.g., “best before,” “sell by,” etc.).

Introduction to GOL’s FDA Registration Services

GOL provides comprehensive FDA registration services to help businesses ensure compliance with U.S. regulations for food, drugs, cosmetics, and medical devices. Our experienced team guides you through the entire registration process, making it straightforward and efficient.

Key Features of Our FDA Registration Services:

1. Expert Consultation:
   • Receive personalized guidance from our FDA compliance experts to understand the specific requirements for your products.
2. Complete Documentation:
   • We assist in preparing and submitting all necessary documentation to the FDA, ensuring accuracy and compliance with regulatory standards.
3. Timely Processing:
   • Our efficient processes and experienced team help expedite your FDA registration, minimizing delays and ensuring timely market entry.
4. Regulatory Updates:
   • Stay informed about any changes in FDA regulations that may affect your products, with regular updates and guidance from our experts.
5. Post-Registration Support:
   • Benefit from ongoing support and consultation even after your registration is complete, ensuring continued compliance and addressing any issues that may arise.

Why Choose GOL for FDA Registration?

• Experienced Team: Our team of experts has extensive experience in FDA regulations and compliance, providing reliable and knowledgeable support.
• Customized Solutions: We tailor our services to meet the unique needs of your business and products, ensuring a smooth and efficient registration process.
• Client-Centric Approach: At GOL, we prioritize our clients’ success and satisfaction, offering dedicated support and personalized service throughout the registration process.

Ensure your products meet FDA requirements and gain access to the U.S. market with confidence. Contact GOL today to learn more about our FDA registration services and how we can assist you.